Jade Aden Interiors

ISO Standards for Clean Rooms & Core Design Requirements

ISO standards for clean rooms

ISO Standards for Clean Rooms & Core Design Requirements

What Are ISO Standards for Clean Rooms?

ISO standards for clean rooms, outlined in ISO 14644, explain how to measure and control airborne particles in closed spaces. These standards specify the maximum number of airborne particles that can be present in a cubic metre. They go from ISO Class 1, which is ultra-clean, to ISO Class 9, which is the least clean.

In the UK, ISO 7 and ISO 8 clean rooms are the most commonly required in pharmaceutical, biotech, and advanced manufacturing settings. To meet ISO 7, for example, a clean room must limit particles ≥0.5µm to 352,000 per cubic metre; ISO 8 increases that threshold to 3,520,000. These figures impact the HVAC specification, filtration method, and zoning layout in the design.

ISO 14644 has been adopted as a British Standard (BS EN ISO 14644-1:2015). Its use is crucial for any project under the oversight of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) or GMP (Annex 1). For more information on clean room classifications, visit ISO 14644-1 on the BSI website.

5 Key Design Considerations for ISO-Compliant Clean Rooms

Designing a clean room to meet ISO standards requires careful coordination. The designer must balance contamination control with regulatory compliance and operational functionality. At Jade Aden Interiors, we integrate technical performance with practical layout planning. This allows us to create clean rooms that support your team’s workflow.

1. Airflow & Contamination Control

Effective particle control is the foundation of clean room performance and begins with:

  • HEPA or ULPA filtration: Removing 99.97% of particles ≥0.3µm
  • Controlled Air Changes Per Hour (ACH): Typically 30–60 for ISO 7 and 10–25 for ISO 8
  • Positive Pressure Systems: Preventing airborne ingress from adjacent areas

When necessary, we create directional airflow systems, utilising either laminar or turbulent flow. Our experts ensure these systems comply with ISO 14644-3 validation protocols. For projects in regulated environments, this ensures airborne contamination stays within permitted limits. Most importantly, it continues to do so even at peak operation.

2. Material Specification

Surfaces, including walls, ceilings, and flooring, must be:

  • Non-porous, resistant to microbial growth, and easy to sanitise
  • Resistant to cleaning agents and chemical exposure
  • Smooth and free from joints or edges to minimise particle accumulation

We install hygienic wall systems, ceiling cladding and seamless flooring designed for clean room use. As a Komfort registered installer, our solutions are tested and compliant with industry standards. They provide lasting durability while maintaining high standards of hygiene.

3. Clean Room Layout & Zoning

A compliant clean room layout must manage traffic flow and minimise the risk of cross-contamination. This includes:

  • Airlocks or gowning areas to separate external and internal zones
  • Defined personnel and material routes to prevent crossover
  • Segregated areas between clean and less clean operations (e.g. ISO 8 to ISO 7)

Our design team collaborates with clients to understand their process flows, regulatory requirements, and spatial constraints. In temperature-controlled labs and pharmaceutical settings, we also design transitions for regulated zones. These features include pass-through hatches and decontamination points.

4. Compliance, Validation & Sector-Specific Standards

To achieve a clean room design, it’s vital to closely follow international and industry standards. Our team ensures alignment from day one by incorporating the following:

  • ISO 14644 classifies air cleanliness levels from ISO 1 to ISO 9. These levels depend on the allowed particle concentrations.
  • EU GMP Annex 1 applies to pharmaceutical and sterile manufacturing. It includes layout design, environmental monitoring, and cleaning validation. The UK’s MHRA regulates these areas.
  • BRCGS alignment is crucial for food production and the use of medical devices. It helps meet both integrated and dual-standard compliance requirements.

We also support your validation process, from airflow qualification to recovery time testing. This helps ensure your facility meets its ISO classification, both when idle and during operation. Our approach is built to help you pass audits, protect processes, and maintain trust.

5. Lighting, Visibility & Operational Safety

Lighting is commonly overlooked in clean room design. However, it significantly affects visibility, safety, and the accuracy of inspections. We specify LED systems that are:

  • Flush-mounted with sealed enclosures to minimise particle accumulation
  • Low-glare, high-lux lighting that supports visual inspections and safe operation
  • Energy-efficient systems, with compatibility for centralised lighting controls

Emergency and task-specific lighting can be added when necessary. All fixtures should be rated for the appropriate Ingress Protection (IP) levels for clean rooms.

Talk to the Experts About Your Clean Room Project

Whether you are building a new clean room or upgrading an existing one, success starts with confident design. From ISO 14644 classifications to specific standards like GMP and BRCGS, every choice is essential. And when the stakes are high, you need a partner who understands both the regulations and your operational goals.

At Jade Aden Interiors, we offer more than 30 years of expertise. We specialise in clean rooms, modular fit-outs, and controlled environments in the South. As a Komfort registered installer, AIS member, and Aspire Defence Approved contractor, we adhere to the highest standards. If you are planning a clean room and need support with layout, compliance, or complete turnkey delivery, we are ready to help.

Call 01425 689199 or contact us to book a consultation or request a free site survey.